- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05808426
Benefits of Online Mahjong by Older Adults
April 16, 2023 updated by: National Yang Ming University
Randomized Trial of Online Mahjong Intervention to Promote Cognitive Function and Health Status in Community-dwelling Middle Aged and Older Adults.
This study aims to examine the clinical efficacy of online Mahjong in improving physical health, cognitive performance, happiness, laboratory biomarkers, and structural brain imaging (magnetic resonance imaging, MRI) by a randomized controlled trial design, and hopefully to expand the scope of healthy aging intervention activities with strong scientific evidence.
Study Overview
Detailed Description
Psychomotor function among older adult's decline was associated with reducing people interaction during pandemic has been reported.
The research focused on examining the benefit and efficacy of digital based Mahjong games with 6-month intervention is very limited or none.
A random control design was conducted with comparing intervention group and with control group, followed the CONSORT guidelines.
Six months program was intervened to ensure the impact of the intervention.
Primary outcome is brain imagery changes between groups, which showed changes in temporal fusiform cortex but not in resting-state fMRI.
The total score of MoCA, delayed recall was increase from baseline to after intervention in experimental group.
Overall cognitive function and visuospatial/executive, in experimental group improved more than control group.
Improving self-rating daily health status as associated with achievement rate of Mahjong game.
Increasing level of resilience was associated with demoralization level, subtraction of cognitive function, and 5th month walking steps.
In addition, affecting incased self -rate overall heath was related to demoralization.
In short, online mahjong intervention has positive impact on older adults in cognitive function , resilience, demoralization and overall quality of life.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taipei, Taiwan, 112
- Center for Geriatrics and Gerontology, Taipei Veterans General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Age ≥ 55 years old.
- More than 6 years of formal education.
- Can communicate in Mandarin and Taiwanese.
- Can accept MRI examination without claustrophobia.
- Can understand the research process, meet the requirements of the research, and can sign the consent form and participate in the subject.
Exclusion Criteria:
- Have engaged in any Mahjong games in the past three months.
- Engaged in Mahjong games more than three times per year in the past three years.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: observation with no intervention group
The control group only performed routine data collection; the research assistant asked the subjects about their usual activities by telephone every month to understand their physical activity in this half of the year.
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Experimental: Mahjong group
The experimental group intervened a Bonus Winner Mahjong developed by Bonus Winner Online Entertainment Co., Ltd.
The participants in experimental group played three times a week, each time requiring at least lasting 30 minutes, for half of a year.
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Bonus Winner Mahjong developed by Bonus Winner Online Entertainment Co., Ltd.
The participants in experimental group played three times a week, each time requiring at least lasting 30 minutes, for half of a year.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in MRI study from baseline to 6 months in the intervention group.
Time Frame: baseline and 6 months
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Change in MRI study from baseline to 6 months in the intervention group.
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baseline and 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Montreal Cognitive Assessment (MoCA)
Time Frame: baseline and 6 months
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Cognitive function measure by MoCA , which comprise a 30-question test.Score range: 0-30, and a score of 26 and higher is considered normal.
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baseline and 6 months
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EuroQol instrument (EQ-5D)
Time Frame: baseline and 6 months
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Quality of life measure by EQ-5D, which include five questions on mobility, self care, pain, usual activities, and psychological status.
Score range: There are three level of the answers for each question, the maximum score of 1 refers to the best condition without problem, and higher scores refers more severe of the issue.
Moreover, the visual analogue scale (VAS) which from 0-100, higher score indicating better health status.
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baseline and 6 months
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International Physical Activity Questionnaire (IPAQ)
Time Frame: baseline and 6 months
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Physical activity measured by IPAQ, indicates that spent being physically active within the prior 7 days.
Score range: There are no established thresholds for presenting MET-minutes, the IPAQ Research Committee proposes that reported as comparisons of median values and interquartile ranges for different populations.
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baseline and 6 months
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Brief Resilience Scale (BRS)
Time Frame: baseline and 6 months
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Resilience measured by BRS to assess ability to bounce back or recover from stress and adversity.
Score range: 6-30, and higher scores refers to higher level of resilience.
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baseline and 6 months
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Demoralization Scale-Mandarin Version (DS-MV)
Time Frame: baseline and 6 months
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Demoralization measure by DS-MV, comprised 24 items and each rated on a five-point Likert scale.Score range: 0-96, and cut-off point score ≥30 was considered to identified demoralization.
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baseline and 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Liang-Kung Chen, PhD, Center for Healthy Longevity and Aging Sciences,National Yang Ming Chiao Tung University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 28, 2020
Primary Completion (Actual)
November 1, 2021
Study Completion (Actual)
March 20, 2022
Study Registration Dates
First Submitted
March 29, 2023
First Submitted That Met QC Criteria
March 29, 2023
First Posted (Actual)
April 11, 2023
Study Record Updates
Last Update Posted (Actual)
April 19, 2023
Last Update Submitted That Met QC Criteria
April 16, 2023
Last Verified
June 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- YM108123F_M
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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